A Study of Nivolumab Combined with Cabozantinib compared to Sunitinib in Patients with Kidney Cancer that was Previously Untreated, Advanced, or that has Spread (CheckMate 9ER)

Phase 1

Conditions: Advanced or Metastatic Renal Cell Carcinoma
MedDRA version: 21.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-000759-20-PL

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 850

Inclusion Criteria

- Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
- No prior systemic therapy for RCC with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340

Exclusion Criteria

- Any active CNS metastases
- Any active, known or suspected autoimmune disease
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to determine whether Nivolumab Combined<br>with Cabozantinib is safe and effective compared to Sunitinib in the<br>treatment of Kidney cancer in patients with previously untreated,<br>advanced, or cancer that has spread;Secondary Objective: To compare overall survival (OS) of Arm A with Arm C in all randomized<br>participants.<br>To evaluate the objective response rate (ORR) per BICR in all<br>randomized participants.<br>To assess overall safety and tolerability in all treated participants.;Primary end point(s): 1. Progression Free Survival (PFS) per blinded independent central<br>review (BICR) of Arm A versus Arm C in all randomized participants<br>;Timepoint(s) of evaluation of this end point: 1. Time Frame: Up to 22 months <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Overall Survival (OS) of Arm A versus Arm C<br>2. Objective Response Rate (ORR)<br>3. Incidence of adverse events (AEs)<br>4. Incidence of Serious Adverse Events (SAEs);Timepoint(s) of evaluation of this end point: 1. Time Frame: Up to 34 months<br>2. Time Frame: Approximately 16 months<br>3. Time Frame: Up to 34 months<br>4. Time Frame: Up to 34 months